DECEMBER 2023LIFE SCIENCES REVIEW8linical trials have undergone significant changes over the decades, both strategically and operationally. These changes have been driven by advancements in technology and a recent emphasis on patient-centered outcomes. For instance, the direct data capture (DDC) methods have enabled electronic data collection directly from the source, which is then automatically transferred to a central database for visualization, eliminating the need for source data verification (SDV). Artificial intelligence (AI) can also play a role in the design and efficiency of non-traditional trials, such as ones incorporating the use of real world data (RWD). Additionally, blockchain technology has the potential to incentivize participants in clinical trials through token rewards or other forms of compensation.The diversification of clinical trials has allowed for more personalized and effective treatments for patients. Digital biomarkers, in particular, have a significant impact on the future of clinical trial. These technologies can be seamlessly integrated into patient-centric and decentralized clinical trials, providing benefits to participants, clinicians, and sponsors. Sensor technology and digital devices have enabled the real-time collection of patient data in their daily lives without requiring frequent hospital or clinic visits. This has accelerated the development of digital biomarkers in digital health technology (DHT). In Japan, there have been moderate use cases of digital biomarkers in clinical research, focusing on evaluating daily activity, sleep and mobility through activity or fitness trackers. However, the use of digital biomarkers as clinical trial endpoints to support labeling claims for therapeutic products is still uncommon, although efforts are emerging.There have been randomized clinical trials (RCTs) that have employed wearable devices to measure clinical endpoints such as stride velocity in patients with Duchenne Muscular Dystrophy and 24-hour cough count in patients with Refractory and/or unexplained chronic cough. The severity of cough can alternatively be assessed by the patient's own visual analog scale (VAS) as a patient-reported outcome (PRO). It can be, however, subjective and may not sufficiently reflect the nocturnal status, while wearable devices can electronically acquire data on patients' biological responses. Continuous glucose monitors are also well-established as passive measurement devices through wearables. However, there are still technical hurdles to overcome for active measurement using digital biomarker, such as cognitive assessment.Biomarkers are particularly compatible with central nervous system (CNS) disorders, including psychiatric and neurological diseases, where subjective clinical assessments are often relied upon for diagnosis. The development of digital biomarkers aided by AI algorisms could be a breakthrough in this area. Among the various biological responses that can be measured, the digital voice biomarker shows promise as a continuous, non-invasive disease monitoring tool that can be also utilized in screening and diagnosis of a broad range of EVOLVING DIGITAL BIOMARKERS IN CLINICAL TRIAL SPACEBy Kazuto Yamada, Senior Director, Head of Clinical Development Planning and supervising five R&D functions, Otsuka PharmaceuticalcKazuto YamadaIN MY OPINION
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